K210324 is an FDA 510(k) clearance for the V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186. This device is classified as a Clamp, Vascular (Class II - Special Controls, product code DXC).
Submitted by Carefusion 2200, Inc. (Vernon Hills, US). The FDA issued a Cleared decision on March 4, 2021, 28 days after receiving the submission on February 4, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K210324 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2021 |
| Decision Date | March 04, 2021 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXC — Clamp, Vascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4450 |